American Surgical Company, LLC: Device Recall
Recall #Z-0287-2025 · 09/18/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0287-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- American Surgical Company, LLC
- Status
- Ongoing
- Date Initiated
- 09/18/2024
- Location
- Salem, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 390 units
Reason for Recall
Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field.
Product Description
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A
Distribution Pattern
CA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.